Log in
RegisterLong t½ drugs [NCA / SHAM]
Thanks Helmut!
From the pilot data n=6, mean t1/2 was ~ 21 hrs, longest t1/2 was 27 hrs.
Well FDA doesn't have the AUCt/AUCi ratio but they do ask for adequate sampling. For those 3 subjects with AUCt/AUCi ratio ~ 60%, 4 datapts which showed very good linear decline were used to determine t1/2. Only one subject had Cmax at 24 hrs(avg Tmax 4-6 hrs). By the way, these subjects showed AUCt/AUCi ratio of ~ 60% for both T and R.
I am leaning toward submitting the study as is since the 3 subjects in question demonstrated bioequivalence between T and R anyway. Some of my colleague suggested analyze the data with and without these 3 subjects and I considered that nonsense.
John
❝ What was the longest half-life in the pilot? Did you try to calculate a CL predicting the worst case?
From the pilot data n=6, mean t1/2 was ~ 21 hrs, longest t1/2 was 27 hrs.
❝ If you are able to estimate elimination in these three subjects reliably (≥3 data points, sufficient quality of the fit) it shouldn’t be a big deal.
Well FDA doesn't have the AUCt/AUCi ratio but they do ask for adequate sampling. For those 3 subjects with AUCt/AUCi ratio ~ 60%, 4 datapts which showed very good linear decline were used to determine t1/2. Only one subject had Cmax at 24 hrs(avg Tmax 4-6 hrs). By the way, these subjects showed AUCt/AUCi ratio of ~ 60% for both T and R.
I am leaning toward submitting the study as is since the 3 subjects in question demonstrated bioequivalence between T and R anyway. Some of my colleague suggested analyze the data with and without these 3 subjects and I considered that nonsense.
John
Complete thread:
- Long t½ drugs jag009 2012-12-05 16:04
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Long t½ drugs Helmut 2012-12-05 19:41
- Long t½ drugsjag009 2012-12-05 22:04
- Long t½ drugs Helmut 2012-12-05 19:41
Ing. Helmut Schütz